(394 days)
Not Found
Wright Medical Acetabular Alignment Guide, Depuy Pinnacle Cup System, Stryker Acetabular Alignment Guide, Aufranc Universal Cup Alignment Guide, Protractors
No
The device is described as a manual mechanical instrument used in conjunction with an Excel spreadsheet for calculations. There is no mention of AI or ML in the description, performance studies, or key metrics.
No.
This device is a surgical instrument used for alignment during hip arthroplasty procedures, not directly for treating a disease or condition.
No
This device is a surgical instrument used for aligning acetabular components during hip arthroplasty procedures. Its primary function is mechanical positioning and guidance, rather than diagnosing a disease or condition. While it uses CT mapping for patient-specific alignment, it does not analyze or interpret medical data to make a diagnosis.
No
The device description clearly states it is a "manual mechanical acetabular positioning device" with physical components like legs, protractors, and a direction pin. While it uses an Excel spreadsheet for calculations, the core device is hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Hip Sextant Instrument System is a manual surgical instrument used during a surgical procedure (hip arthroplasty) to physically align components within the patient's body. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for "align[ing] the acetabular components during hip arthroplasty procedures," which is an in-vivo (within the body) application.
- Device Description: The description details a mechanical device used to physically interact with the patient's pelvis during surgery.
While the device uses information from CT mapping and an Excel spreadsheet for calculations, these are tools to guide the surgical procedure, not to perform diagnostic testing on a biological sample.
N/A
Intended Use / Indications for Use
The Hip Sextant Instrument System is a manual surgical instrument used to align the acetabular components during hip arthroplasty procedures.
Product codes
OSF
Device Description
The HipSextant Instrument is a manual mechanical acetabular positioning device. The devices is used in conjunction with CT mapping of the individual patients pelvis.
The instrument has three legs which land on the pelvis. The legs form three points which define the sextant plane. The sextant has two protractors that are adjusted to orientate a direction pin in the direction of the desired orientation of the acetabular component.
During surgery a small pin is placed into the ischium and a cannulated leg and the sextant are seated onto the ischium. The second leg is seated onto the lateral side of the anterior spine by placing an arthroscopic style trocar through a cannula. Finally, a third leg is also seated using a trocar. With the sextant firmly docked onto the pelvis, the cup impactor is then aligned with the sextant direction pin.
The device is used with an Excel spreadsheet which is used to assist the surgeon in performing calculations regarding alignment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT mapping
Anatomical Site
pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
manual surgical instrument
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device has been subjected and successfully passed clinical and nonclinical testing including the following:
- Sterilization Validation
- Cleaning Validation (including protein residual)
- Repeated autoclave studies to evaluate performance and wear
- Validation of software used in conjunction with the device to perform calculations.
- Clinical experience
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Wright Medical Acetabular Alignment Guide, Depuy Pinnacle Cup System, Stryker Acetabular Alignment Guide, Aufranc Universal Cup Alignment Guide, Protractors
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
510(k) Summary
Device: Hip Sextant Instrument System (K093491)
Submission Type: Traditional 510(k)
DEC - 9 2010
Date Prepared [21 cFR 807.92(a)(1)]: Revised October 29, 2010
Submitter's Information [21 CFR 807.92(a)(1)]
This 510(k) is being submitted by Orchid Design on behalf of Surgical Planning Associates, Inc.
Contact:
Curtis Raymond Orchid Design 80 Shelton Technology Center - Shelton, CT 06484 Tel: (203) 922-0105 - Fax: (203) 922-0130 e-mail: curt.raymond@orchid-orthopedics.com
Sponsor / Manufacturer:
Surgical Planning Associates, Inc 43 Riverside Avenue, #192 Medford, MA 02155
FDA Establishment Registration#: Pending
Trade Name, Common Name, Classification (21 CFR 807.92(1)(2)) Device Trade Name: Hip Sextant
Device Common, Usual, or Classification Names:
- Orthopedic Stereotaxic System .
- . Acetabular cup alignment guides
- Acetubular Positioner ●
- Socket positioned .
- . Trocar
Classification: Class 2; ref. 21 CFR 21 §882.4560 (OSF – Patient Specific Manual Orthopedic Stereotaxic System).
1
Predicate Devices [21 CFR 807.92(a)(3)]
- Wright Medical Acetabular Alignment Guide, Class 1 Exempt .
- Depuy Pinnacle Cup System Class 1. Exempt .
- Stryker Acetabular Alignment Guide, Class 1 Exempt .
- Aufranc Universal Cup Alignment Guide Class 1 Exempt and . Preamendment
- Protractors Class 1 exempt and Pre-amendment .
The subject device as well as the predicate devices are composed of medical grade metal and reusable. The Depuy, Stryker, and Wright Medical instruments were design to be used with hip systems from the respective manufacturers. Both the Hip Sextant and the Aufranc Universal Cup Alignment Guide can be used during any hip reconstructive procedure regardless of the type of implant being used.
Both the HipSextant device and Protractors have measurement numbers or indicators on the device to assist the surgeon with alignment. The other devices do not have such numeric indicators.
Description of the Device [21 CFR 807.92(a)(4)]
The HipSextant Instrument is a manual mechanical acetabular positioning device. The devices is used in conjunction with CT mapping of the individual patients pelvis.
The instrument has three legs which land on the pelvis. The legs form three points which define the sextant plane. The sextant has two protractors that are adjusted to orientate a direction pin in the direction of the desired orientation of the acetabular component.
During surgery a small pin is placed into the ischium and a cannulated leg and the sextant are seated onto the ischium. The second leg is seated onto the lateral side of the anterior spine by placing an arthroscopic style trocar through a cannula. Finally, a third leg is also seated using a trocar. With the sextant firmly docked onto the pelvis, the cup impactor is then aligned with the sextant direction pin.
The device is used with an Excel spreadsheet which is used to assist the surgeon in performing calculations regarding alignment.
Intended Use [21 CFR 807.92(a)(5)]
The Hip Sextant Instrument System is a manual surgical instrument used to align the acetabular components during hip arthroplasty procedures.
2
Technological Characteristics [21 CFR 807.92(a){6}}
Surgical Planning Associates, Inc. believes that the subject device is substantially equivalent to the cited predicate devices. These types of devices are typically exempt from 510(k). However, the subject device utilizes a nontraditional plane for the navigation of acetabular cup positioning, which we believe can be appropriately reviewed under a 510(k) notification. Nevertheless, the conclusion of substantial equivalency is based on the identical indications for use, design concept, level of surgical invasiveness, and that all cited instruments are metal and reusable. Equivalence is further substantiated by clinical and nonclinical data.
Performance Data [21 cFR 807.92(b)(1)]
The subject device is composed of medical grade biocompatible materials.
The subject device has been subjected and successfully passed clinical and nonclinical testing including the following:
- Sterilization Validation ●
- Cleaning Validation (including protein residual) .
- · . Repeated autoclave studies to evaluate performance and wear
- Validation of software used in conjunction with the device to perform ● calculations.
- Clinical experience .
Conclusion 121 CFR 807.92(b)(3)1
We believe the subject device is substantially equivalent to the predicate device and conclude that the subject device is as safe and effective as the predicate devices.
3
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Surgical Planning Associates % Orchid Design Mr. Joseph Azary 80 Shelton Technology Center Medford, Massachusetts 02155
DEC - 9 2010
Re: K093491
Trade/Device Name: Hip Sextant Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OSF Dated: November 05, 2010 Received: November 08, 2010
Dear Mr. Azary:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be clevice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to Conninered prices that have been reclassified in accordance with the provisions of the Federal Food, Drug. devices mat have been recuire approval of a premarket approval appiroval appin&ation (PMA). and Cosmetic Act (Act) that do not require to the general controls provisions of the Act. The You may, dicierore, market the devices, editories and the coursely of the productions of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adultieration. Ticase note: CDTCP doos not be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 acove). Existing major regulations affecting your device can be may be subject to addinonal controls. Encluding on Janes 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition found in the Code of I ederal Regarations)
publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that I DA s issuation of a bucking of a backless with other requirements of the Act
4
Page 2 - Mr. Joseph Azary
or any Federal statutes and regulations administered by other Federal agencies. You must or any Federal statutes and regulations administered of ot registration and listing (21
comply with all the Act's requirements, including, but norsting of medical comply with all the Act 's requirements, merce reporting (reporting of medical
CFR Part 807); labeling (21 CFR Part 801); medical device reguirements as CFR Part 807); labeling (21 CFR Part 807); pood manufacturing practice requirements as set
device-related adverse events) (21 CFR 803); good manufacturing practices the elect device-related adverse evenis) (21 CFR Pat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and if applicable, the elec forth in the quality systems (QS) regulation (21-51-14) of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
s (1580) html (1980) (1992) (1988) (1988) (1988) (1980) hm for If you desire specific advice for your device on our called fires/ucm liness and lises of Compliance . Also deast go to http://www.da.gov/AboutrDA/Cchices of Compliance Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance of CDLCFP Part the Center for Devices and Radiongical riculties of the consemarket notification" (21 CFR Part
note the regulation entitled, "Misbranding by reference varies vegalation (2 note the regulation entitled, "Misolanding of relevelse to premiers
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
CFR Part 803), please go to 110,://www.rad.governma.government of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general information. on your Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (800) 030-2641 01 (30) ijicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
incerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
K09 349/
Hip Sextant Instrument System
The Hip Sextant Instrument System is a manual surgical instrument used to align the acetabular components during hip arthroplasty procedures.
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Niel Reiden Gorman
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K093491 510(k) Number ________________________________________________________________________________________________________________________________________________________________
DEC - 9 2010
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